Dr. Emmanuelle Voisin founded Voisin Consulting Life Sciences (VCLS) in 1997. The firm has become a leading advisor to Biotech, Pharma and Medtech manufacturers for the development, registration, and launch of innovative medical technologies across international markets.
Emmanuelle has 30 years’ experience in drug development. Her expertise lies in non-conventional development strategies, maximizing the use of regulatory mechanisms and innovative approaches, to bring innovative technologies to patients.
Emmanuelle also provides strategic advice for interacting with FDA and EMA. She participates in due diligence and negotiations for licensing and acquisitions.
Previously, Emmanuelle launched the operations for Quintiles in Southern European countries, with a specific focus on managing the French and Spanish operations. Prior to this, Emmanuelle held a position as Reviewing Pharmacologist and Toxicologist with the US FDA CDER Division of Antiviral Drug Products, where she was in charge of reviewing applications for new AIDS therapies. She gained industry experience both from the Laboratoires Servier in France and Laboratoires Besins Iscovesco (now Besins International) in the USA. Emmanuelle acquired her background in academic research in the USA at the National Institute of Mental Health, NIMH, Neuroscience Branch, and in France with national research units, CNRS/INSERM at Institut Gustave Roussy, Villejuif, where she obtained her Ph.D. in Pharmacology studying the bioactivation of a novel anticancer molecule. Emmanuelle holds a pharmacy degree and was a Resident in the Paris Hospital Authorities (Ancien Interne des Hôpitaux de Paris).
Emmanuelle has published a number of articles in international peer-reviewed journals, covering various scientific and regulatory aspects of innovative drug development, as well as global challenges of the biotechnology industry. She is a member of the Organisation of Professionals in Regulatory Affairs (TOPRA), as well as an active member of Eucope, EuropaBio, France Biotech, and other local industry associations.
Emmanuelle is also a member of Avicenna Alliance, an association endorsed and tasked by the European Commission, dedicated to the development of in silico medicine. She leads the In-Silico Policy Development Working Group to ensure a forward-looking policy framework to facilitate the large scale deployment of in silico technology and their acceptance by health authorities.
She is a member of the Advisory Board of the Swiss-based biopharmaceutical company, the leader in Alzheimer’s disease, AC Immune. Emmanuelle is also on the Board of Endodiag.
Emmanuelle is regularly invited as a key expert speaker at international conferences.
Resources by Emmanuelle M. Voisin, PhD
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Human Microbiomes in Health and Disease: Strategic Options for Regulatory Science and Healthcare Policy
This article describes the human microbiota and microbiomes’ strategic role in personalizing health and disease management, which is rapidly demanding…
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A Regulatory Landscape Shift for In Silico Clinical Trials
Modelling and simulation (M&S) has grown to become a reliable approach to better understand and optimize key decisions related to…
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Keeping Up with Innovation The challenge for regulators
Big data, mobile health and synthetic biology: An overview of some of the changes and measures were taken by regulators…
